Biofluid-based diagnostic screening system and methods of use

Abstract

A biofluid-based diagnostic screening system and associated methods are disclosed for screening a volume of biofluid of a patient for an at least one medical condition. In at least one embodiment, the system provides a lateral flow test strip, a test housing sized and configured for removably receiving the test strip therewithin, and a user application residing locally in memory on an imaging device and configured for screening a volume of biofluid of a patient, as deposited on the test strip, for an at least one medical condition.

What is claimed is: 
     
         1 . A biofluid-based diagnostic screening system configured for screening a volume of biofluid of a patient for an at least one medical condition, the system comprising:
 a lateral flow test strip providing a rigid backing on which is positioned:
 an at least one sample pad configured for receiving and absorbing a volume of the patient's biofluid; 
 a corresponding at least one detection zone containing an at least one biological component for detecting a presence or absence of an at least one target analyte in the volume of the patient's biofluid, the at least one biological component immobilized and arrayed into each of a test line and a control line within said detection zone; and 
 an identification code that identifies a test type to be performed on the volume of the patient's biofluid by the system using the test strip; 
   a test housing sized and configured for removably receiving the test strip therewithin, the test housing comprising:
 a substantially planar top panel configured for temporarily supporting an imaging device thereon; 
 an opposing, substantially planar bottom panel; 
 a sidewall extending vertically between the top and bottom panels, along a perimeter edge of the top and bottom panels, the top panel, bottom panel and sidewall cooperating to form an enclosed space within the test housing; 
 a strip placeholder positioned on an upper surface of the bottom panel and configured for assisting in the proper positioning of the test strip within the test housing; 
 an upper surface of the top panel providing an imaging aperture positioned so as to be substantially vertically aligned with the at least one detection zone of the test strip when the test strip is positioned on the strip placeholder within the test housing, the imaging aperture sized for providing an image capture device of the imaging device visual access into the enclosed space within the test housing; and 
 an at least one image calibration indicia positioned on the upper surface of the bottom panel or the backing of the test strip, the image calibration indicia configured for assisting with a calibration of the image capture device of the imaging device; and 
   a user application residing locally in memory on the imaging device, the user application configured for, upon an appropriate volume of the patient's biofluid being deposited onto the at least one sample pad of the test strip, the test strip subsequently being positioned on the strip placeholder within the test housing, and the imaging device being positioned on the upper surface of the top panel of the test housing so that the image capture device is positioned over the imaging aperture of the top panel:
 capturing an image of the identification code of the test strip using the image capture device of the imaging device; 
 determining the at least one test type to be performed on the volume of the patient's biofluid based on the captured image of the identification code; 
 obtaining a local temperature relative to the imaging device; 
 setting an appropriate calibration curve metric and a timer duration for each of the at least one test type, based on the at least one target analyte of the at least one test type as a function of the local temperature; and 
 for each of the at least one test type to be performed on the volume of the patient's biofluid, upon the associated timer duration being reached for said test type:
 capturing, via the image capture device of the imaging device, at least one image of the corresponding at least one detection zone of the test strip and the image calibration indicia; 
 adjusting a white balance of the captured at least one image of said detection zone based on the image calibration indicia; 
 calculating a pixel density value of the test line of said detection zone, based on an intensity of said test line depicted in the at least one image; 
 obtaining an analyte concentration value corresponding to the pixel density value of the test line of said detection zone; and 
 communicating the obtained analyte concentration value to at least one of the patient or a medical service provider of the patient. 
 
   
     
     
         2 . The biofluid-based diagnostic screening system of  claim 1 , wherein the at least one target analyte is matrix metalloproteinase (“MMP”). 
     
     
         3 . The biofluid-based diagnostic screening system of  claim 2 , wherein the at least one biological component of the at least one detection zone comprises antibodies for at least one of active MMP-8, total MMP-8, and latent MMP-8. 
     
     
         4 . The biofluid-based diagnostic screening system of  claim 2 , wherein the least one detection zone of the test strip is further configured for measuring a quantity of an at least one ubiquitous protein, thereby enabling the user application to determine a measure of specific activity of MMP-8 in the patient's biofluid and, in turn, normalize the levels of MMP-8 per unit of ubiquitous protein in the patient's biofluid. 
     
     
         5 . The biofluid-based diagnostic screening system of  claim 1 , wherein the at least one biological component of the at least one detection zone further comprises a labeled antibody. 
     
     
         6 . The biofluid-based diagnostic screening system of  claim 1 , wherein the at least one biological component of the at least one detection zone further comprises an enzyme amplified antibody. 
     
     
         7 . The biofluid-based diagnostic screening system of  claim 1 , wherein one or more of the top panel, bottom panel and sidewall, or select portions thereof, of the test housing are constructed out of a translucent material so as to allow an amount of diffused light from an external environment to enter the enclosed space within the test housing during use of the system. 
     
     
         8 . The biofluid-based diagnostic screening system of  claim 1 , wherein the sidewall of the test housing provides a strip aperture sized for receiving the test strip therethrough and configured for allowing the test strip to be removably positioned within the test housing. 
     
     
         9 . The biofluid-based diagnostic screening system of  claim 8 , wherein the strip placeholder is positioned substantially adjacent to the strip aperture. 
     
     
         10 . The biofluid-based diagnostic screening system of  claim 1 , wherein the strip placeholder is comprised of visual indicia that is printed on or otherwise affixed to the upper surface of the bottom panel. 
     
     
         11 . The biofluid-based diagnostic screening system of  claim 1 , wherein the strip placeholder is a physical structure sized for approximating the dimensions of the test strip so as to removably receive the test strip therewithin. 
     
     
         12 . The biofluid-based diagnostic screening system of  claim 1 , wherein the test housing has a height that is substantially equal to or greater than a focal length of the image capture device of the imaging device. 
     
     
         13 . The biofluid-based diagnostic screening system of  claim 1 , wherein the at least one image calibration indicia is positioned substantially adjacent to the strip placeholder, proximal to the at least one detection zone of the test strip when the test strip is positioned on the strip placeholder. 
     
     
         14 . The biofluid-based diagnostic screening system of  claim 1 , wherein the step of the user application obtaining an analyte concentration value corresponding to the pixel density value of the test line of said detection zone, further comprises the steps of the user application:
 accessing a database containing a plurality of pixel density values and corresponding analyte concentration values;   locating at least one of the stored pixel density values in the database that most closely matches the pixel density value of the test line of said detection zone; and   obtaining the analyte concentration value corresponding to each of the at least one of the stored pixel density values in the database that most closely matches the pixel density value of the test line of said detection zone.   
     
     
         15 . The biofluid-based diagnostic screening system of  claim 1 , wherein the step of the user application obtaining an analyte concentration value corresponding to the pixel density value of the test line of said detection zone, further comprises the step of the user application calculating the analyte concentration value by using the calibration curve metric as a function of the pixel density value. 
     
     
         16 . The biofluid-based diagnostic screening system of  claim 1 , further comprising a biofluid collection device configured for collecting a volume of the patient's biofluid and subsequently depositing an appropriate volume of the biofluid onto the at least one sample pad of the test strip. 
     
     
         17 . The biofluid-based diagnostic screening system of  claim 1 , wherein the identification code is a visual code configured for being obtained by the imaging device via the image capture device of the imaging device. 
     
     
         18 . A biofluid-based diagnostic screening system configured for screening a volume of biofluid of a patient for an at least one medical condition, the system comprising:
 a lateral flow test strip providing a rigid backing on which is positioned:
 an at least one sample pad configured for receiving and absorbing a volume of the patient's biofluid; 
 a corresponding at least one detection zone containing an at least one biological component for detecting a presence or absence of an at least one target analyte in the volume of the patient's biofluid, the at least one biological component immobilized and arrayed into each of a test line and a control line within said detection zone; and 
 an identification code that identifies a test type to be performed on the volume of the patient's biofluid by the system using the test strip; 
   a biofluid collection device configured for collecting a volume of the patient's biofluid and subsequently depositing an appropriate volume of the biofluid onto the at least one sample pad of the test strip;   a test housing sized and configured for removably receiving the test strip therewithin, the test housing comprising:
 a substantially planar top panel configured for temporarily supporting an imaging device thereon; 
 an opposing, substantially planar bottom panel; 
 a sidewall extending vertically between the top and bottom panels, along a perimeter edge of the top and bottom panels, the top panel, bottom panel and sidewall cooperating to form an enclosed space within the test housing; 
 a strip placeholder positioned on an upper surface of the bottom panel and configured for assisting in the proper positioning of the test strip within the test housing; 
 an upper surface of the top panel providing an imaging aperture positioned so as to be substantially vertically aligned with the at least one detection zone of the test strip when the test strip is positioned on the strip placeholder within the test housing, the imaging aperture sized for providing an image capture device of the imaging device visual access into the enclosed space within the test housing; and 
 an at least one image calibration indicia positioned on the upper surface of the bottom panel or the backing of the test strip, the image calibration indicia configured for assisting with a calibration of the image capture device of the imaging device; and 
   a user application residing locally in memory on the imaging device, the user application configured for, upon an appropriate volume of the patient's biofluid being deposited onto the at least one sample pad of the test strip, the test strip subsequently being positioned on the strip placeholder within the test housing, and the imaging device being positioned on the upper surface of the top panel of the test housing so that the image capture device is positioned over the imaging aperture of the top panel:
 capturing an image of the identification code of the test strip using the image capture device of the imaging device; 
 determining the at least one test type to be performed on the volume of the patient's biofluid based on the captured image of the identification code; 
 obtaining a local temperature relative to the imaging device; 
 setting an appropriate calibration curve metric and a timer duration for each of the at least one test type, based on the at least one target analyte of the at least one test type as a function of the local temperature; and 
 for each of the at least one test type to be performed on the volume of the patient's biofluid, upon the associated timer duration being reached for said test type:
 capturing, via the image capture device of the imaging device, at least one image of the corresponding at least one detection zone of the test strip and the image calibration indicia; 
 adjusting a white balance of the captured at least one image of said detection zone based on the image calibration indicia; 
 calculating a pixel density value of the test line of said detection zone, based on an intensity of said test line depicted in the at least one image; 
 obtaining an analyte concentration value corresponding to the pixel density value of the test line of said detection zone; and 
 communicating the obtained analyte concentration value to at least one of the patient or a medical service provider of the patient. 
 
   
     
     
         19 . A method for screening a volume of biofluid of a patient for an at least one medical condition using the biofluid-based diagnostic screening system of  claim 18 , the method comprising the steps of:
 implementing a user application residing in memory on an imaging device;   collecting a volume of the patient's biofluid using the biofluid collection device;   depositing an appropriate volume of the biofluid from the biofluid collection device onto the at least one sample pad of the test strip;   positioning the test strip on the strip placeholder within the test housing;   positioning the imaging device on the upper surface of the top panel of the test housing so that the image capture device is positioned over the imaging aperture of the top panel;   the user application capturing an image of the identification code of the test strip using the image capture device of the imaging device;   the user application determining the at least one test type to be performed on the volume of the patient's biofluid based on the captured image of the identification code;   the user application obtaining a local temperature relative to the imaging device;   the user application setting an appropriate calibration curve metric and a timer duration for each of the at least one test type, based on the at least one target analyte of the at least one test type as a function of the local temperature; and   for each of the at least one test type to be performed on the volume of the patient's biofluid, upon the associated timer duration being reached for said test type:
 the user application capturing, via the image capture device of the imaging device, at least one image of the corresponding at least one detection zone of the test strip and the image calibration indicia; 
 the user application adjusting a white balance of the captured at least one image of said detection zone based on the image calibration indicia; 
 the user application calculating a pixel density value of the test line of said detection zone, based on an intensity of said test line depicted in the at least one image; 
 the user application obtaining an analyte concentration value corresponding to the pixel density value of the test line of said detection zone; and 
 the user application communicating the obtained analyte concentration value to at least one of the patient or a medical service provider of the patient. 
   
     
     
         20 . The method of  claim 19 , wherein the step of the user application obtaining an analyte concentration value corresponding to the pixel density value of the test line of said detection zone, further comprises the step of the user application calculating the analyte concentration value by using the calibration curve metric as a function of the pixel density value.